# COVID Protection After Transplant (CPAT) Multicenter Adaptive Trial

> **NIH NIH U01** · JOHNS HOPKINS UNIVERSITY · 2021 · $6,941,821

## Abstract

Solid organ transplant recipients experience high mortality from COVID-19 due to a combination of
immunosuppression and comorbidities. Although SARS-CoV-2 vaccination has been highly effective in the
general population, recent studies show that solid organ transplant recipients are less likely to develop
protective antibody responses. In addition, long term studies of safety, including immunologic sequela such as
rejection, and de novo donor-specific antibody formation are lacking.
We propose a Multicenter Randomized Adaptive Design Trial to investigate strategies for CPAT (COVID
Protection After Transplant). This trial will build on results from a CPAT Pilot Trial in 200 kidney transplant
reipients which will investigate the safety and immunogenicity of 3rd dose of a SARS-CoV-2 mRNA vaccines in
recipients who fail to develop high level antibodies after a standard 2 dose series. That trial will identify key
correlates of risk and efficacy. This trial will incorporate that data to investigate additional protective strategies
including the use of different vaccine platforms and changes in immunosuppression in 800 solid organ
transplant recipients with suboptimal anti-spike antibody responses across 15 US transplant centers. This trial
will personalize randomization to candidate arms with the highest probability of success using a Bayesian
framework. In conjuction, we will perform novel, comprehensive virologic and immunologic mechanistic studies
to better understand vaccine-associated immunity over time.
Our multidisciplinary team includes experts in Transplant Surgery, Infectious Diseases, Epidemiology,
Biostatistics, Pathology, Virology, and Immunology. Our team has experience successfully enrolling and
conducting multicenter transplantation trials (U01AI134591, U01AI138897) and will leverage existing
infrastructure for operations, data management, analysis, and safety reporting.
In summary, this Multicenter Adaptive Design CPAT Trial will determine the immunogenicity and safety of
novel SARS-CoV-2 vaccination strategies in 800 transplant recipients across the United States. Important
mechanistic studies will further fundamental understanding of development of protective immune responses in
this vulnerable population.

## Key facts

- **NIH application ID:** 10457200
- **Project number:** 3U01AI138897-04S1
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Christine Marie Durand
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $6,941,821
- **Award type:** 3
- **Project period:** 2021-09-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10457200

## Citation

> US National Institutes of Health, RePORTER application 10457200, COVID Protection After Transplant (CPAT) Multicenter Adaptive Trial (3U01AI138897-04S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10457200. Licensed CC0.

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